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Chronic Obstructive Airways Disease ExacerbatedNCT07348003

Examining the Effectiveness of Single-Limb Exercise Training for COPD Patients During Exacerbation Periods

A study testing Single Limb Exercise Training and Routine Exercise in people with Chronic Obstructive Airways Disease Exacerbated, run by Alper Kemal Gürbüz at 1 site in Turkey (Türkiye).

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Resistance exercise applications during acute exacerbations of Chronic Obstructive Pulmonary Disease (COPD) are employed to enhance functional capacity and prevent muscle atrophy by increasing muscle strength. Read more about this study

Who is it for?
Any age
What is being tested?
Single Limb Exercise Training and Routine Exercise
Could I receive a placebo?
No, everyone receives an active treatment
How many people
30 participants
Where
1 siteTurkey (Türkiye)
Study dates
2 Jan 2026to 25 Jun 2026
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages Any age
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • Hospital admission due to an acute COPD exacerbation.
  • Not currently enrolled in an active pulmonary rehabilitation program.
  • Absence of any additional neurological disorders.

Who cannot join

  • Heart failure classified as New York Heart Association (NYHA) Class III or IV. Unstable mental status (indicated by a Mini-Mental State Examination (MMSE) score of 24).
  • History of major surgery within the last three months. Presence of malignancies.

Trial locations and contacts

1 site in 1 country.

Turkey (Türkiye)1 site
  • Hacettepe University

    Ankara, Ankara, 06300

Other trials in Turkey (Türkiye)

About this study

Resistance exercise applications during acute exacerbations of Chronic Obstructive Pulmonary Disease (COPD) are employed to enhance functional capacity and prevent muscle atrophy by increasing muscle strength.

Owing to the limited cardiorespiratory reserve of COPD patients, single-limb exercises are better tolerated compared to traditional bilateral exercises. A study conducted by Vogiatzis et al. (2009) indicated that single-leg exercises require lower ventilation and result in more efficient oxygen consumption than bilateral exercises. This physiological advantage may be effective in reducing muscle weakness by increasing exercise endurance in COPD patients with restricted respiratory capacity.

The present study aims to demonstrate that single-limb resistance exercise is an effective rehabilitation method for increasing functional exercise capacity in patients during COPD exacerbations compared to a control group. Furthermore, the therapeutic effects of single-limb resistance exercises on dyspnea perception, fatigue, anxiety, and depression will be established. The study will also show that these exercises are both feasible and safe within rehabilitation protocols during the exacerbation period.

Read the detailed description

Pathophysiology and Rehabilitation in Acute Exacerbation of COPD An acute exacerbation of Chronic Obstructive Pulmonary Disease (COPD) represents an acute process that accelerates disease progression and exerts systemic effects. This period is characterized by a sudden worsening of primary symptoms, such as dyspnea, increased sputum volume, and heightened sputum viscosity. Exacerbations lead to increased hospitalization rates, diminished quality of life, and elevated mortality among COPD patients. According to the GOLD 2024 report, a COPD exacerbation is defined as an event characterized by increased dyspnea, cough, and sputum that develops in less than 14 days and necessitates a change in treatment. These episodes are generally attributed to increased airway infection, environmental pollution, or other inflammatory triggers.

During these periods, respiratory functions decline acutely, leading to impaired oxygenation and physiological stress. Research indicates a significant decrease in skeletal muscle function during exacerbations, with muscle weakness becoming a prominent clinical feature. This acute weakness develops due to various factors, including systemic inflammation, nutritional deficiencies, and the use of corticosteroids. Observations show a reduction in myoblast determination proteins and insulin-like growth factor-I levels in skeletal muscle during the exacerbation process; this suggests that physical inactivity is a critical factor in acute muscle dysfunction.

Most patients face conditions requiring inactivity, such as bed rest, during an exacerbation. Inactivity causes a rapid decline in muscle strength, particularly in older individuals; one study demonstrated that 10 days of bed rest resulted in a 15% reduction in quadriceps strength. Under stressful conditions, this effect becomes even more pronounced, and medications such as corticosteroids can exacerbate the detrimental effects of inactivity. Limitation of physical activity during this period both accelerates skeletal muscle loss and adversely affects the long-term mobilization capabilities of patients.

Treatment during a COPD exacerbation aims to alleviate symptoms and improve quality of life. Management typically involves bronchodilators (β2-agonists and anticholinergics), inhaled corticosteroids, and antibiotics. Furthermore, systemic corticosteroids can rapidly improve symptoms by suppressing inflammation. Approaches such as pulmonary rehabilitation, exercise, and breathing techniques can reduce dyspnea by increasing functional capacity . Non-invasive positive pressure ventilation (NIPPV) is utilized for patients experiencing severe respiratory distress. To prevent infections, influenza and pneumococcal vaccinations are recommended, while smoking cessation and avoiding air pollution also reduce the risk of exacerbation.

Exercise performed during a COPD exacerbation helps patients maintain physical capacity and accelerates the recovery process. However, exercises during this period must be meticulously planned, as acute exacerbations lead to impaired respiratory function and increased systemic inflammation. Exercise interventions are typically initiated at low intensity to preserve cardiorespiratory function, support muscle strength, and ensure general mobility.

Low-intensity cardiorespiratory endurance exercises, such as walking or stationary cycling, are recommended during the exacerbation period. These exercises improve oxygenation in skeletal muscles. A study by Vaes et al. (2017) stated that low-intensity cardio exercises initiated during a COPD exacerbation are effective in preserving functional capacity. During an exacerbation, weakness may be observed particularly in the lower extremities, such as the quadriceps. Lower extremity exercises initiated at low resistance levels help patients maintain muscle function and reduce skeletal muscle loss. The study by Greening et al. showed that low-intensity resistance exercises during the exacerbation period are safe and effective for increasing muscle strength .

In COPD, single-limb exercises are implemented to increase tolerance to physical activity and preserve muscle strength, especially during the exacerbation period. These exercises aim to work muscle groups in isolation by focusing on one limb, thereby minimizing energy consumption and reducing the risk of exercise intolerance. During single-limb exercises, muscles operate with lower oxygen consumption because the other limb remains in a resting position; this is better tolerated by COPD patients experiencing severe dyspnea or fatigue The primary objective of our study is to determine the effectiveness of single-limb resistance exercises in patients with COPD during the exacerbation phase. This research aims to evaluate the potential of this exercise modality to improve the physiological and psychological status of patients during an acute episode.

H0: Single-limb exercise training applied to COPD patients during exacerbation does not change functional exercise capacity compared to the control group.

H1: Single-limb exercise training applied to COPD patients during exacerbation changes functional exercise capacity compared to the control group.

Hypothesis 2:

H02: Single-limb exercise training applied to COPD patients during exacerbation does not change the perception of dyspnea and fatigue compared to the control group.

H2: Single-limb exercise training applied to COPD patients during exacerbation changes the perception of dyspnea and fatigue compared to the control group.

Hypothesis 3:

H03: Single-limb exercise training applied to COPD patients during exacerbation does not change peripheral muscle strength compared to the control group.

H3: Single-limb exercise training applied to COPD patients during exacerbation changes peripheral muscle strength compared to the control group.

Being tested
Single Limb Exercise Training, Routine Exercise
Keywords
copd, exacerbated, exercise
Medical subject headings
Pulmonary Disease, Chronic Obstructive, Motor Activity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Single Limb Exercise TrainingOther

    Participants will perform unilateral resistance exercises for six major muscle groups (shoulder flex/abd, elbow flex, hip flex, knee flex/ext) using free weights in a seated position. The intensity is set at 50-70% of 1RM, consisting of 2 sets of 8 repetitions per limb. This 8-week program will be conducted twice weekly as an adjunct to routine hospital physiotherapy and standard inpatient physiotherapy, including breathing retraining (diaphragmatic and pursed-lip breathing) and thoracic expansion exercises.

  • Routine ExerciseOther

    Physiotherapy Intervention: Just standard inpatient physiotherapy, including breathing retraining (diaphragmatic and pursed-lip breathing) and thoracic expansion exercises.

Study groups in NCT07348003
Study groupRoleWhat they receive
Exercise groupActive comparatorSingle-Limb Resistance Exercise Group: Participants will perform unilateral resistance exercises for six major muscle groups (shoulder flex/abd, elbow flex, hip flex, knee flex/ext) using free weights in a seated position.
Receives: Other: Single Limb Exercise Training; Other: Routine Exercise
Control GroupOtherRoutine Physiotherapy Intervention: The control group will undergo standard inpatient physiotherapy, including breathing retraining (diaphragmatic and pursed-lip breathing) and thoracic expansion exercises.
Receives: Other: Routine Exercise

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 1. Functional Exercise Capacity

    30-Second Sit-to-Stand Test (30-sec STS): Functional capacity will be assessed using a chair with a height of 43.2 cm and back support. Patients, with arms crossed over their chests, will be instructed to complete as many full stands as possible within 30 seconds. Two practice trials will be performed before recording the final count.

    Measured: Up to 8 weeks

  2. Dyspnea

    Modified Medical Research Council (mMRC) Scale: Dyspnea perception during daily activities will be recorded. The five levels of the scale will be explained in detail to the participants to determine their perceived respiratory distress

    Measured: Up to 8 weeks

  3. Muscle Strength Assessment

    Muscle strength will be measured using a digital dynamometer (Commander Echo Manual Muscle Tester, Lafayette Instrument Co., USA). The best of three consecutive measurements will be recorded

    Measured: Up to 8 weeks

Secondary outcomes (4)
  1. Respiratory Muscle Strength

    Maximal Inspiratory Pressure (MIP) and Maximal Expiratory Pressure (MEP) will be assessed using a portable manometer (Pony FX, Cosmed, Italy). For MIP, patients will perform a maximal inspiration from residual volume; for MEP, a maximal expiration from total lung capacity. The best of three measurements with less than 10% variability will be recorded

    Measured: Up to 8 weeks

  2. Pulmonary Function Test (PFT)

    Pulmonary functions will be measured in a seated position using a spirometer. Parameters including FVC (Liter (L)), FEV₁ (Liter (L)), TLC (Liter (L)), PEF (L/s) will be recorded as absolute values and percentages of predicted values based on age, height, weight, and gender

    Measured: Up to 8 weeks

  3. Anxiety and Depression

    Hospital Anxiety and Depression Scale (HADS): This 14-item scale consists of two subscales (7 items each for anxiety and depression). The Turkish validity and reliability of the scale have been established, and permission for use has been secured

    Measured: Up to 8 weeks

  4. Functional Exercise Capacity

    6-Minute Walk Test (6MWT): Prior to the test, resting heart rate, blood pressure, oxygen saturation ($SpO_2$), and respiratory rate will be measured. Patients will walk the maximum possible distance on a 30-meter flat indoor course for 6 minutes. Dyspnea and fatigue during the test will be evaluated using the Borg Scale

    Measured: Up to 8 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted16 Jan 2026
  2. Study start2 Jan 2026
  3. Primary completion1 May 2026
  4. Study completion25 Jun 2026

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
This study is an interventional clinical trial designed to evaluate the effects of an exercise therapy program. Participants will be prospectively assigned to one of two study arms: an intervention group and a control group.
Masking
Single blind
Who is masked
Participant
Enrolment
30 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07348003
Sponsor's protocol ID
GurbuzTez
Status last verified
Jul 2026
First submitted
29 Dec 2025
Last updated
24 Jul 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing Single Limb Exercise Training and Routine Exercise in people with Chronic Obstructive Airways Disease Exacerbated, run by Alper Kemal Gürbüz at 1 site in Turkey (Türkiye).

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 24 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

1. Functional Exercise Capacity (time frame: Up to 8 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jul 2026.

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